Main taks: • Management of the regulatory process for Phase I/II/III clinical trials• Preparation of documentation for submission to the Ethics Committees and to AIFA• E-Submission clinical trials and amendments using National Monitoring Centre for Clinical Trials (OsSC)• Contacts with Ethics Committees, AIFA and Sponsor• Organization/management/delivery of the submission package• Revision (Quality Control) of the reports of approval

In order to achieve the Master degree in Medical Biotechnology I did an internship of ten months in the molecular biology laboratory at the Bellaria Hospital.I have carried out a degree thesis in pathological anatomy, dealing mainly with pituitary tumor and cystic lesions, and especially craniopharyngiomas. In more detail I joined to the histopathological analysis the two techniques of molecular biology high sensitivity/specificity, such as the ASLNAqPCR (specific mutation technique) and the 454 GS-Junior Roche (sequencer high sensitivity) for the identification of mutations of the genes BRAF and CTNNB1 in pituitary lesions.The achieved results have allowed us to demonstrate how the combination of molecular diagnostic tests to the normal routine pathological-anatomical can be of great help in discriminating between neoplastic pituitary and cystic lesions.Furthermore, the high specificity of mutational analysis of BRAF and CTNNB1 excludes the risk of false positives.In addition, the fact that these molecular techniques also provide a semi-quantitative data on the percentage of mutated allele allows to have a further means of "compatibility" between diagnosis/histological suspicion and mutational analysis.

•Techniques of extraction, quantification and retro-transcription of RNA•Technique of DNA and cDNA amplification from products of chromatin immunoprecipitation (ChIP)•Analysis of proteins (Western Blot)